Vehicle Automation Impact on Drivers

Neuroimaging Clinical Trial

— AUTODRIVE  

Official title:

On the Highway to Autonomous Driving: How is Automation Changing Humans: Investigations of Drivers' Behaviors, Representations and Neural Processes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03893006
• Other study ID #: 69HCL19_0141
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2019
• Est. completion date: July 8, 2023

Study information

• Verified date: July 2021
• Source: Hospices Civils de Lyon
• Contact: Jordan Navarro, MD
• Phone: 00 33 4 78 77 30 52
• Email: jordan.navarro[@]univ-lyon2.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the context of ever-increasing automation in surface vehicles, automation impact on drivers will be investigated through three complementary research axes undertaken under simulated driving: Axe 1 (Cognitive ergonomics), how automation is impacting driving behaviors and visual explorations? Axe 2 (Experimental psychology), how automation is impacting drivers' mental representations of their own driving abilities? Axe 3 (Neuroimaging), how automation is modifying the car driving neural network? And what are drivers' mental representations neural bases? The project tackle both applied and basic research issues using an original experimental neuro ergonomics approach. AUTODRIVE will bring original data on human-machine cooperation, mental representations, cognitive control and brain processes depending on the characteristics of the automation used over a significant period of time (six weeks) on a large sample (N=120) of experienced and inexperienced drivers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 8, 2023
• Est. primary completion date: July 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 45 Years

Eligibility

Inclusion Criteria:

• To be between the ages of 22 and 45 years old
• Having given an informed consent for the study
• Being registered with the French Social Security System
• No driving license for 60 participants
• Driving license for 4 years or more for 60 participants

Exclusion Criteria:

• No signature on the consent form
• Inability to read or write French.
• Neurologic or psychiatric illness, known or revealed during the inclusion visit
• Substance intake ( taking psychoactive medications or recreational drugs) on the day of the experiment
• Noise intolerance
• Need of vision glasses to drive
• Persons under curators or deprived of civil rights or deprived of their freedom
• Unable to fill a questionnaire (severe cognitive troubles)
• Subjects must not have metallic or electronic implants in the body : pacemakers or pacemaker wires, open heart surgery, artificial heart valve, brain aneurysm surgery, middle ear implant, hearing aid, braces or extensive dental work, cataract surgery or lens implant, implanted mechanical or electrical device, or artificial limb or joint o foreign metallic objects in the body (bullets, BBs, pellets, shrapnel, or metalwork fragments) or current or past employment as machinists, welders or metal workers, tattoos near the head or neck regions, permanent makeup
• Claustrophobia

Related Conditions & MeSH terms

• Automation
• Behaviors
• Driving
• Neuroimaging

Intervention

Device:
• Level of vehicle automation
From no automation of the vehicle to full automation through warnings, shared control and partly automated automation levels.

Locations

Country	Name	City	State
France	Laboratoire d'Etude des Mécanismes Cognitifs (EMC)	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOLD effect	Functional magnetic resonance imaging measures brain activity by detecting changes associated with blood flow This technique relies on the fact that cerebral blood flow and neuronal activation are coupled. When an area of the brain is in use, blood flow to that region also increases. The primary form of fMRI uses the blood-oxygen-level dependent (BOLD) contrast in response to an experimental condition (Ogawa, Lee, Kay, & Tank, 1990), allowing researchers to track changes in oxygen consumption on the brain, and therefore brain activity. BOLD effect is computed by assessing the different relaxation times (T1 and T2) in the brain, as T1 and T2 are different in function of regional cerebral blood flows.; The outcome will be a change between mean BOLD effect oven session 1 versus session 2 versus session 3.	Repetition Time (TR) :every 3 seconds, during the 3 fMRI sessions of respectively 1 hour, 0,75 hour and 0,75 hour. fMRI session 2 occurs 3 weeks after fMRI session 1 and 3 weeks before fMRI session 3.
Secondary	Behavioral changes	Participants will be asked to drive through a variety of driving situations in a driving simulator simulated environment equipped with an eye-tracker. The measure collected will be drivers' behaviors on the steering wheel and pedals as well as their visual behaviors.; The outcome will be a change in the number of actions on the steering wheel (a), pedals (b) and gaze dispersion (c) on the visual scene across the time points.	Two experimental sessions of an hour, one before and one after the six weeks of automated driving. Plus six driving sessions of 0,5 hour, one driving session the first day of each experimental week.